The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Beth Israel Deaconess Medical Center Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00459069

Purpose

The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer cells have unique markers that distinguish them from normal cells of the body. These markers can potentially serve as targets for the immune system. Dendritic cells are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.

Condition	Intervention	Phase
Multiple Myeloma	Biological: Dendritic Cell Tumor Fusion Vaccine	Phase I

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MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To assess the toxicity associated with vaccination of patients multiple myeloma with dendritic cell(DC)/tumor cell fusions co-administered with GM-CSF. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine whether evidence of tumor specific cellular and humoral immunity can be induced by serial vaccination with DC/tumor cell fusion cells co-administered with GMCSF [ Time Frame: 5 years ] [ Designated as safety issue: No ]
to determine if vaccination with DC/tumor cell fusions co-administered with GM-CSF results in clinical disease response. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	29
Study Start Date:	July 2004
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Vaccine administered on weeks 0, 3 and 6

Detailed Description:

To create the study vaccine, cells will be removed from the participants tumor and fused (mixed) with powerful immune system stimulating cells (dendritic cells) obtained from the participants blood.
Not everyone who participates in this study will be receiving the same amount of study vaccine. A small group of people will be enrolled into the study and given a certain dose. If they tolerate it well, the next group of people enrolled will receive a higher dose. This will continue until the highest dose level tolerated is determined.
Once the screening tests are completed and it is determined the participant is eligible, they will undergo some baseline procedures. In an effort to make the study vaccine, tumor cells and dendritic cells will be collected from the participant. Tumor cells may be collected from bone marrow or from a collection of tumor cells called a plasmacytoma. A decision will be made based upon the location of the cancer.
A bone marrow aspiration/biopsy will be performed during the following time points: at screening, prior to the first vaccination, and at 1 month, 3 months, and 6 months after the final study vaccination. These will be used to assess and follow the participants multiple myeloma.
Leukapheresis will be performed to obtain dendritic cells. This procedure takes 2 to 4 hours to and involves the collection of a large number of white blood cells. Dendritic cells will be generated in the laboratory from white blood cells. If not enough white blood cells are collected, the participant may be asked to return to the clinic for an additional leukapheresis procedure.
Before each vaccine is administered (weeks 0, 3, 6) the following study tests and procedures will be performed: skin test; blood test, physical exam and 24-hour urine collection. A physical exam and blood tests will be performed on the weeks when the participant does not receive the vaccine (weeks 1,2,4,5,7,8).
The study schedule will consist of a fixed dose of the fused (mixed) cell vaccine under the skin every 3 weeks. Each study vaccine will be accompanied by an injection of GM-CSF. Participants will receive 2 or more vaccines depending upon the total number of fusion cells made, the dose the participant is assigned to receive and their response to the study vaccine.
Follow-up after the vaccine treatment is completed will consist of the following: blood collection (1, 3 and 6 months after final study vaccination); bone marrow aspiration/biopsy (1, 3 and 6 months after final study vaccination); physical exam (1, 2, 3, 4, 5 and 6 months after final study vaccination); radiologic tumor assessment (1, 3 and 6 months after final study vaccination.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of multiple myeloma: Stage I not requiring initiation of chemotherapy; Stage I, II or III patients felt to be clinically stable and having received at least one prior chemotherapy regimen
Measurable disease as defined by a history of an elevated M component in plasma or urine or free kappa.lambda light chains in serum
18 years of age or older
ECOG Performance Status of 0-1 with a greater than nine week life expectancy
> 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
Laboratory results within ranges outlined in protocol
Negative pregnancy test and adequate contraception method(s) must be documented

Exclusion Criteria:

History of clinically significant venous thromboembolism
Received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
Chemotherapy or radiation therapy 4 weeks prior to the first vaccine
Clinically significant autoimmune disease
HIV positive
Serious intercurrent illness
Taking systemic corticosteroids within 4 weeks of treatment with study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459069

Contacts

Contact: David Avigan, MD	617-667-9920	davigan@bidmc.harvard.edu
Contact: Dilani Dombagoda	617-667-5984	ddombago@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02114
Contact: David Avigan, MD 617-667-9920 davigan@bidmc.harvard.edu
Contact: Dilani Dombagoda 617-667-5984 ddombago@bidmc.harvard.edu
Sub-Investigator: Jacalyn Rosenblatt, MD
Sub-Investigator: James D Levine, MD
Sub-Investigator: Robin Joyce, MD
Sub-Investigator: Lynne Uhl, MD
Sub-Investigator: David McDermott, MD
Sub-Investigator: Donald Kufe, MD
Sub-Investigator: Jeffrey Zwicker, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

David Avigan, MD

Beth Israel Deaconess Medical Center

More Information

Responsible Party:	Beth Israel Deaconess Medical Center ( David Avigan, MD )
Study ID Numbers:	03-240
Study First Received:	April 10, 2007
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00459069
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

tumor vaccine
GM-CSF

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009